Method and apparatus for manufacturing a capsule

ABSTRACT

A method of manufacturing a capsule  12  for holding a substance  14  including providing a capsule body  2  having a closed end  5 , an opposed open end  6  and a predetermined length defined between the ends  5, 6 ; providing a diaphragm  4  having a closed end  7 , an opposed open end  8  and a predetermined length defined between the ends  7, 8 ; partially filling the body  2  with substance  14 ; inserting the closed end  7  of the diaphragm  4  into the open end  6  of the body  2  such that regions of the body  2  and the diaphragm  4  overlap one another with the open ends of the capsule body  2  and the diaphragm  4  being flush, thereby closing off the open end  6  of the body  2  and defining a chamber  104  within which the substance  14  is held; and heat welding the flush ends of the body  2  and the diaphragm  4  to one another to hermetically seal the chamber  104.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of International Application No.PCT/IB2012/055374 filed Oct. 5, 2012 and claims the benefit of SouthAfrican Application No. 2011/07330 filed Oct. 6, 2011, the disclosuresof which are incorporated herein by reference in their entirety

FIELD OF INVENTION

This invention relates to a method and apparatus for manufacturing acapsule of a type suitable for holding a substance which is required tobe held in hermetic isolation. In this specification the term “non-toxicgas” must be interpreted to mean any gas which is non-toxic to a humanor animal body when ingested and which specifically does not containoxygen.

SUMMARY OF INVENTION

According to a first aspect of the invention there is provided a methodfor manufacturing a capsule for holding a substance which is required tobe held in hermetic isolation, the method including the steps of:

providing a first capsule portion of flexible material for holding thesubstance, the first capsule portion having a closed end, an opposedopen end and a predetermined length dimension defined between the endsthereof;

providing a second capsule portion of flexible material having a closedend, an opposed open end and a predetermined length dimension definedbetween the ends thereof, which is shorter than the length dimension ofthe first capsule portion;

at least partially filling the first capsule portion with the substance;

inserting the closed end of the second capsule portion into the open endof the first capsule portion until the open ends of the first capsuleportion and the second capsule portion are aligned substantially flushwith one another and such that a region of the second capsule portionoverlaps a region of the first capsule portion so as to close off theopen end of the first capsule portion and define a chamber within whichthe substance is held; andbonding the substantially flush aligned open ends of the first capsuleportion and the second capsule portion to one another, thereby tohermetically seal the chamber.

The method may include supporting the open ends of the first capsuleportion and the second capsule portion while bonding the substantiallyflush aligned open ends of the first capsule portion and the secondcapsule portion to one another.

The method may include supporting inner and outer sides of the first andsecond capsule portions at an open end region defined adjacent thesubstantially flush aligned open ends of the first capsule portion andsecond capsule portion.

The method may include bonding the substantially flush aligned open endsof the first capsule portion and the second capsule portion to oneanother by applying heat and pressure to the open ends of the first andsecond capsule portions, so as to fuse the open ends of the capsuleportions to one another.

The method may include bonding the overlapping regions of the firstcapsule portion and the second capsule portion to one another.

The method may include bonding the overlapping regions to one another byapplying heat and pressure to the overlapping regions.

The method may include providing a gas-tight chamber in order to achievea controlled gaseous environment within the chamber, the methodincluding locating the first and second capsule portions within thechamber and inserting the closed end of the second capsule portion intothe open end of the first capsule portion while in the chamber.

The method may include providing a non-toxic gas environment within thechamber and inserting the closed end of the second capsule portionwithin the first capsule portion while the capsule portions are locatedwithin the non-toxic gas environment.

The method may include applying a partial vacuum to the chamber therebyto reduce gas pressure within the chamber to a sub-atmospheric pressurewhen inserting the closed end of the second capsule portion into theopen end of the first capsule portion.

The first capsule portion may comprise a hollow cylindrical tubular bodywhich defines the open end and the closed end, the closed end beingdome-shape.

The second capsule portion may comprise a hollow cylindrical tubularbody which defines the open end and the closed end, the closed end beingdome-shape.

The method may include the steps of providing a cap; at least partiallyfilling the second capsule portion with an additional substance; andsecuring the cap to one of the first capsule portion and the secondcapsule portion so as to define an additional chamber within which theadditional substance is held.

The method may include securing the cap to one of the first capsuleportion and the second capsule portion in an arrangement wherein the capcloses the open end of the second capsule portion.

The first capsule portion and the second capsule portion may both beformed of digestible material rendering the capsule digestible.

The first capsule portion, the second capsule portion and the cap may beformed of digestible material, rendering the capsule digestible.

According to a second aspect of the invention there is provided anapparatus for manufacturing a capsule for holding a substance which isrequired to be held in hermetic isolation, the apparatus including:

first capsule receiving means including at least one first capsulereceiving formation which is dimensioned and configured for receivingtherein a first capsule portion of flexible material for holding thesubstance therein, the first capsule portion having a closed end, anopposed open end and a predetermined length dimension defined betweenthe ends thereof;capsule filling means including one or more nozzles for dispensing thesubstance, the capsule filling means being operable for at leastpartially filling the first capsule portion which is supported, in use,by the first capsule receiving formation;second capsule handling means including at least one second capsulehandling formation which is configured for handling a second capsuleportion of flexible material having a closed end, an opposed open endand a predetermined length dimension defined between the ends thereof,which is shorter than the length dimension of the first capsule portion,the second capsule handling means being displaceable between:a first condition wherein the second capsule handling formation of thesecond capsule handling means is spaced apart from the first capsulereceiving formation of the first capsule receiving means; anda second condition wherein the second capsule handling formation isoperable to insert a closed end of the second capsule portion handledthereby within the first capsule portion received by the first capsulereceiving formation until the open ends of the first and second capsuleportions are aligned substantially flush with one another and such thata region of the second capsule portion overlaps a region of the firstcapsule portion thereby closing off the open end of the first capsuleportion so as to form an assembled capsule defining a chamber withinwhich the substance is held; andcapsule bonding means for bonding the substantially flush aligned openends of the first capsule portion and the second capsule portion of eachassembled capsule to one another, thereby to hermetically seal thechamber.

The first capsule receiving formation may be configured and dimensionedfor supporting an open end region of the first capsule portion definedadjacent the open end of the first capsule portion.

The second capsule handling formation may be configured and dimensionedto be inserted through the open end of the second capsule portion forsupporting an open end region of the second capsule portion definedadjacent the open end of the second capsule portion.

The capsule bonding means may be in the form of at least one capsulebonding element for applying heat and pressure to the first and secondcapsule portions of the assembled capsules for bonding the first andsecond capsule portions to one another.

The capsule bonding element may define an end engaging formation whichis configured and dimensioned for engaging the substantially flushaligned open ends of the first and second capsule portions for applyingheat and pressure to the open ends for bonding the open ends of thefirst and second capsule portions to one another.

The capsule bonding element may have a second capsule engaging formationwhich is configured and dimensioned for engaging an inner side of thesecond capsule portion for applying heat and pressure to the secondcapsule portion for bonding the overlapping regions of the first andsecond capsule portions to one another.

The apparatus may include a gas-tight chamber within which the first andsecond capsule portions are located when inserting the first capsuleportion into the second capsule portion when forming an assembledcapsule, thereby to achieve a controlled gaseous environment within thechamber.

The apparatus may include a vacuum device for applying a partial vacuumto the chamber for reducing gas pressure within the chamber tosub-atmospheric pressures.

BRIEF DESCRIPTION OF THE DRAWINGS

Further features of the invention are described hereinafter by way of anon-limiting example of the invention, with reference to and asillustrated in the accompanying diagrammatic drawings. In the drawings:

FIG. 1 shows a sectional side view of a capsule produced in accordancewith the method of manufacturing a capsule, in accordance with the firstaspect of the invention;

FIG. 2 shows a sectional side view of another embodiment of a capsuleproduced in accordance with the method of manufacturing a capsule, inaccordance with the first aspect of the invention;

FIG. 3 shows a fragmentary perspective view of an apparatus formanufacturing a capsule, in accordance with a second aspect of theinvention;

FIG. 4 shows a perspective view of a capsule support tray of theapparatus of FIG. 3;

FIG. 5 shows a fragmentary sectional side view of a capsule fillingassembly of the apparatus of FIG. 3;

FIG. 6 shows a fragmentary sectional side view of a vacuum chamberassembly and a diaphragm inserting assembly of the apparatus of FIG. 3,both illustrated in raised positions;

FIG. 7 shows a fragmentary sectional side view of the vacuum chamberassembly and the diaphragm inserting assembly of FIG. 6, bothillustrated in lowered positions;

FIG. 8 shows a fragmentary sectional side view of the vacuum chamberassembly and diaphragm inserting assembly of FIG. 6, with the vacuumchamber assembly illustrated in the lowered position and the diaphragminserting assembly illustrated in the raised position;

FIG. 9 shows a fragmentary sectional side view of a capsule bondingassembly of the apparatus of FIG. 3, illustrated in a raised position;and

FIG. 10 shows a fragmentary, sectional side view of the capsule bondingassembly of FIG. 9, illustrated in a lowered position.

DETAILED DESCRIPTION OF THE DRAWINGS

With reference to FIGS. 1 and 3 to 10 of the drawings, an apparatus inaccordance with a second aspect of the invention is designated generallyby the reference numeral 10. The apparatus 10 is configured formanufacturing a capsule 12 in accordance with the method formanufacturing a capsule, in accordance with a first aspect of theinvention.

The capsule 12 is in the form of a digestible hard gelatine capsule forholding a substance such as, for example Omega-3 oil 14 which, whencontained in a capsule, is required to be held in hermetic isolation fortwo main reasons. Firstly, because Omega-3 oil 14 is in a flowableliquid state and, as such, must be held in a liquid-tight chamber withinthe capsule. Secondly, because Omega-3 oil 14 is susceptible todegradation by oxidation when exposed to oxygen present in theatmosphere. The capsule 12 comprises, broadly, a first capsule portionin the form of a capsule body 2 and a second capsule portion in the formof a diaphragm 4. The capsule body 2 is of a flexible gelatinousmaterial and is in the form of hollow cylindrical tubular body whichdefines a closed end 5 and an opposed open end 6 and which has apredetermined length dimension defined between the ends 5, 6 thereof.The diaphragm 4 is of a flexible gelatinous material having a hollowcylindrical tubular body which defines a closed end 7 and an opposedopen end 8 and which has a predetermined length dimension definedbetween the ends 7, 8 thereof, which is shorter than the lengthdimension of the capsule body 2.

As is illustrated in FIG. 3 of the drawings, the apparatus 10 includes,broadly, first capsule receiving means in the form of a number ofcapsule support trays 16; a capsule filling assembly 20; a vacuumchamber assembly 22; second capsule handling means in the form of adiaphragm inserting assembly 24; and capsule bonding means in the formof a capsule bonding assembly 28.

With reference to FIGS. 3 and 4 of the drawings, each capsule supporttray 16 comprises an aluminium plate 30 having forty two hollowreceptacles 32 defined therein; a peripheral rubber seal 34; and fortytwo internal passages 36 which extend through the aluminium plate 30from bottom end regions 38 of the aluminium plate 30 to a lowermost partof a different one of the receptacles 32, the purpose of which will beexplained in more detail hereinbelow. The receptacles 32 are spaced anequal distance apart from one another and are arranged in a gridarrangement comprising six rows by seven columns. Each receptacle 32 isconfigured and dimensioned for receiving a capsule body 2. Morespecifically, each receptacle 32 is configured and dimensioned so as tosupport an open end region of the capsule body 2 defined adjacent theopen end 6 of the capsule body 2.

Each capsule support tray 16 is displaced, in use, to various positionson the apparatus which correspond to various operational stations of theapparatus 10. More specifically, each capsule support tray 16, isdisplaced, in use, sequentially between: a capsule filing station,wherein the capsule support tray 16 is disposed beneath the capsulefilling assembly 20; a vacuum-insertion station, wherein the capsulesupport tray 16 is disposed beneath the vacuum chamber assembly 22 andbeneath the diaphragm inserting assembly 24; and a capsule bondingstation, wherein the capsule support tray 16 is disposed beneath thecapsule bonding assembly 28.

As is illustrated in FIGS. 3 and 5 of the drawings, the capsule fillingassembly 20 includes a movable capsule filling head 49 and a metereddispenser 53. The capsule filling head 49 includes seven nozzles 52which are spaced an equal distance apart from one another and which arealigned in a row, so that the position of each nozzle 52 correspondswith a particular receptacle 32 of the aluminium plate 30 locatedbeneath it, as shown in FIG. 5 of the drawings. The rows of nozzles 52are sequentially moved to positions wherein the nozzles 52 arepositioned above each row of the receptacles 32 of the aluminium plate30. The metered dispenser 53 is operable to deliver a specific metereddose of Omega-3 oil 14 to each nozzle 52, for partially filling eachcapsule body 2 which is supported within the receptacles 32 of thecapsule support tray 16.

With reference to FIGS. 3 and 6 to 8 of the drawings, the vacuum chamberassembly 22 comprises a vacuum chamber housing 54; a vacuum chamberdisplacing assembly 55 for displacing the vacuum chamber housing 54; avacuum port 58 and a nitrogen delivery port 60. The vacuum chamberhousing 54 has a sealing formation 64 defined on a lower peripheraledge; and a handle formation 62 extending from the housing 54, thepurpose of which will be described in more detail hereinbelow. Thevacuum chamber displacing assembly 55 comprises a winch (not shown)having a steel cable 84 with a hook 86 at a free end of the steel cable84 connected to the handle formation 62 of the housing 54. The vacuumchamber displacing assembly 55 is operable to displace the housing 54between a raised position, as shown in FIGS. 3 and 6 of the drawings anda lowered position, as shown in FIGS. 7 and 8 of the drawings, whereinthe sealing formation 64 of the housing 54 sealingly engages the rubberseal 34 of the capsule support tray 16, so as to define an internalvacuum chamber 56 which is defined between the housing 54 and thecapsule support tray 16. The vacuum port 58 is connected to a vacuumpump (not shown) so as to form a partial vacuum within the vacuumchamber 56 when the vacuum pump is operated. The nitrogen delivery port60 is connected to a source of nitrogen gas for delivering nitrogen gasto the vacuum chamber 56.

With reference to FIGS. 3 and 6 to 8 of the drawings, the diaphragminserting assembly 24 is mounted within the housing 54 of the vacuumchamber assembly 22 and includes forty two diaphragm inserting rods 90and a hydraulically-operated rod-displacing arrangement 85 fordisplacing the diaphragm inserting rods 90. Each diaphragm inserting rod90 has a threaded end (not shown), an opposite end which is connected toa second capsule handling formation in the form of a mandrel 88; and ahollow internal passage 91 extending from the threaded end of the rod 90to the opposite end thereof. Each mandrel 88 has a hollow centralpassage 89 defined therethrough and is configured for handling andsupporting a diaphragm 4. More specifically, each mandrel 88 isconfigured and dimensioned to be inserted through an open end 8 of adiaphragm 4 so as to be received within the diaphragm 4 in a snugsliding fit, and is shaped and dimensioned to correspond to a shape anddimension of an inner side 102 of the diaphragm 2. More specifically,each mandrel 88 is dimensioned and configured for supporting the openend 8 of the diaphragm 4. The rod displacing arrangement 85 comprisesfour guide posts 107, a carrier plate 103; forty two springs 105 andnuts 92; an actuator plate 106 and hydraulic actuator 108; and a movablepiston 101. The guide posts 107 are mounted at upper ends thereof to thehousing 54 of the vacuum chamber assembly 22. The carrier plate 103 isslidably received on the guide posts 107 and has 42 equi-spacedapertures which extend therethrough, through which the diaphragminserting rods 90 are received. Each spring 105 is received on adifferent one of the diaphragm inserting rods 90 and the nuts 92 arethreaded onto the threaded ends of the diaphragm inserting rods 90, asillustrated in FIGS. 6 to 8 of the drawings. The hydraulic actuator 108is operable to displace the piston 101 for displacing the carrier plate103 and the diaphragm inserting rods 90 mounted thereto, for reasonswhich will be explained in more detail hereinbelow.

In use, the vacuum chamber displacing assembly 55 displaces the housing54 into its lowered position, as shown in FIGS. 7 and 8 of the drawings,wherein the sealing formation 64 of the housing 54 sealingly engages therubber seal 34 of the capsule support tray 16. The vacuum pump isactivated so as to draw air out of the vacuum chamber 56 so as to form apartial vacuum within the vacuum chamber 56 so as to reduce internalpressure within the vacuum chamber 56 to a pressure of between 10 kPa to70 kPa. Nitrogen gas is then introduced into the vacuum chamber 56 viathe nitrogen delivery port 60 to increase the internal pressure withinthe vacuum chamber 56 to a pressure of 20 kPa to 90 kPa, whichparticularly is below atmospheric pressure for reasons which will beexplained in more detail hereinbelow.

In use, the rod displacing arrangement 85 is operable to displace thepiston 101 for displacing the inserting rods 90 and the mandrels 88between a first condition, as shown in FIG. 6 of the drawings, whereinthe mandrels 88 are spaced apart from the receptacles 32 of the capsulesupport trays 16 and a second condition, shown in FIG. 7 of thedrawings, wherein the mandrels 88 are operable to insert a closed end 7of each diaphragm 4 supported thereon, within a different one of thecapsule bodies 2, supported by the receptacles 32 of the capsule supporttrays 16, until the open ends 6, 8 of the capsule body 2 and thediaphragm 4 are aligned substantially flush with one another, and suchthat a region of each diaphragm 4 overlaps a region of a different oneof the capsule bodies 2, thereby closing off the open ends 6 of thecapsule body 2 thereby to form an assembled capsule 12 defining achamber 104 in which the Omega-3 oil 14 is held.

It will be appreciated that the receptacles 32 and the mandrels 88together support the open ends 6, 8 of the capsule body 2 and thediaphragm 4 and inner and outer sides of overlapping region of thecapsule body 2 and the diaphragm 4, as shown in FIG. 7 of the drawings,during insertion of the closed end 7 of the diaphragm 4 into the openend 6 of the capsule body 2. The provision of support for an outer sideof the capsule body 2 and an inner side of the diaphragm 4 andparticularly for the open ends 6, 8, is advantageous during insertion,as this ensures that the open ends 6, 8 of the capsule body 2 and thediaphragm 4 do not distort and/or change shape when the closed end 7 ofthe diaphragm 4 is inserted within the capsule body 2. It will beunderstood in this regard that gelatine capsules are particularlyfragile and easily distort and/or rupture when relatively small forcesare applied thereto. Any distortion to the shape of the capsule body 2will also hamper removal of the capsule body 2 from the receptacle 32.

With reference to FIGS. 3, 9 and 10 of the drawings, the capsule bondingassembly 28 comprises a capsule bonding head 118, a support structure120 for supporting the capsule bonding head 118 and a hydraulic heatingmandrel actuator 122. The capsule bonding head 118 has forty two capsulebonding elements in the form of heating mandrels 124 mounted to lowerends of rods 126 which project from a lower end of the bonding head 118,as shown in FIGS. 9 and 10 of the drawings. The heating mandrels 124 arespaced a predetermined distance apart from one another. Morespecifically, the spacing between the heating mandrels 124 correspondswith the spacing between the receptacles 32 of the aluminium plate 30 ofthe capsule support trays 16. More specifically, as illustrated in FIGS.9 and 10 of the drawings, each heating mandrel 124 is located above adifferent one of the receptacles 32 of the capsule support tray 16. Eachheating mandrel 124 has a generally cylindrical configuration asillustrated in FIGS. 9 and 10 of the drawings, and includes a diaphragmengaging formation 128 and an end engaging formation 129. The diaphragmengaging formation 128 is configured and dimensioned for engaging theinner side 102 of the diaphragm 4 and for applying heat and pressure tothe diaphragm 4 when the diaphragm engaging formation 128 of the heatingmandrel 124 is inserted through the open end 8 of the diaphragm 4, asillustrated in FIG. 10 of the drawings. The end engaging formation 129is configured and dimensioned for engaging the substantially flushaligned open ends 6,8 of the capsule body 2 and the diaphragm 4,respectively, for applying heat and pressure to the open end 8 of thediaphragm 4 and the open end 6 of the capsule body 2 for bonding theopen ends 6, 8 of the capsule body 2 and the diaphragm 4, respectively,to one another. The hydraulic heating mandrel actuator 122 is operableto displace the heating mandrels 124 between a raised position as shownin FIG. 9 of the drawings, wherein each heating mandrel 124 is spacedaway from the capsule support tray 116 and a lowered position, whereineach heating mandrel 124 is inserted into an open end 7 of a diaphragm4, as illustrated in FIG. 10 of the drawings.

In use, each heating mandrel 124 is heated to a temperature of between100° C. to 120° C. (optimally 110° C.) and applied to the diaphragm 4for a period of approximately five to ten seconds, as illustrated inFIG. 10 of the drawings. In use, the diaphragm engaging formation 128 ofthe heating mandrel 124 supports, forms and heat welds overlapping partsof the capsule body 2 and the diaphragm 4 to one another, so as to forma fused overlapping wall region 109, as shown in FIG. 10 of thedrawings. The fused overlapping wall region 109 comprises between 0.8 mmand 1.5 mm of overlapping parts of the capsule body 2 and the diaphragm4 which are heat welded to one another.

It will be appreciated that inner and outer sides of the capsule body 2and the diaphragm 4 and the open ends 6, 8 thereof, are supported by thereceptacles 32 and the diaphragm engaging formations 128 of the heatingmandrels 124 during bonding of the overlapping parts of the diaphragm 4and the capsule body 2 and during bonding of the aligned open ends 6, 8,as illustrated in FIG. 10 of the drawings. More specifically, as can beseen from FIG. 10 of the drawings, the diaphragm engaging formations 128and the receptacles 32 together support inner and outer sides ofoverlapping parts of the capsule body 2 and the diaphragm 4, and supportthe ends 6, 8, when the capsule body 2 and the diaphragm 4 are heatwelded to one another. The applicant believes that the supporting of theinner and outer sides of the capsule body 2 and the diaphragm 4 and thesupporting of the open end 6, 8, during bonding the capsule body 2 andthe diaphragm 4 to one another, is also advantageous to ensure properand optimal alignment and orientation of the capsule body 2 and thediaphragm 4 relative to one another. The applicant has found that thesupporting, as described hereinabove, ensures that the capsule 12 isproperly formed and hermetically sealed. Furthermore, the applicantenvisages that supporting the capsule body 12 and the diaphragm 4 duringbonding, as described hereinabove, limits the possibility of distortionand/or collapse of the capsule body 2 and the diaphragm 4 duringbonding.

It will also be understood that, in use, the nitrogen gas providedwithin the chamber 104 reduces concentrations of atmospheric oxygenwithin the chamber 104 and thereby reduces the rate of oxidation of theOmega-3 oil 14. Furthermore, by providing a sub-atmospheric gas pressurewithin the chamber 104, the possibility of the Omega-3 oil 14 seepingout of the chamber 104 is significantly reduced. In addition, theapplicant has found that reducing the gas pressure within the chamber104 to a pressure below atmospheric pressure, is particularlyadvantageous during bonding of the overlapping regions of the diaphragmand the capsule body to one another. In this regard, the applicant hasfound that during bonding, the mandrel 124 also heats up the Omega-3 oil14 in the chamber 104, causing it to expand. As a result of thisexpansion, the pressure within the chamber 104 increases. To overcomethis problem, the internal pressure within the chamber 104 is reduced toa pressure which is sufficiently below atmospheric pressure, such that,when heat and pressure are applied during bonding, the internal pressurewithin the chamber 104 remains below atmospheric pressure particularlyafter the expansion of the Omega-3 oil 14 due to heating of thediaphragm and capsule body. This ensures that the internal pressurewithin the chamber 104 is at or below atmospheric pressure afterbonding, so as to ensure that the chamber 104 is not pressurised to apressure above atmospheric pressure, so as to ensure an effectivehermetic seal. This reduction of the pressure within the chamber 104, isthus beneficial as increased internal pressure within the chamber 104 isundesirable as it may compromise the sealing of the chamber 104.Furthermore, the applicant has found that reducing gas pressure withinthe chamber 104 to a pressure below atmospheric pressure, is alsoadvantageous after bonding. More specifically, the applicant has foundthat users of the capsule 12 often store the capsules 12 in hotenvironments such as, for example, in their cars where ambienttemperatures are increased. The applicant has found that reducing gaspressure within the chamber 104 when manufacturing the capsule to apressure below atmospheric pressure specifically enables the capsules tobe used in relatively hot environments which may increase pressurewithin the chamber 104. This ensures that the capsule body 2 and thediaphragm 4 are not pressurized by internal pressure within the chamber104 to pressures above ambient pressure when ambient temperatures towhich the capsules 12 are exposed rise to relatively higher levels. Inthis regard, it will be appreciated that it is likely that the hermeticseal will be compromised if internal pressure within the chamber 104exceeds atmospheric pressure and remains at this higher pressure for anextended period of time.

The apparatus 10 further includes a support tray vacuum system (notshown) and an inserting rod vacuum system (not shown). The support trayvacuum system is operable to produce a partial vacuum within theinternal passage 36 of the capsule support tray 16, so as to produce asuction in the lower end of the receptacles 32 for holding the capsulebodies 2 in position within the receptacles 32 when withdrawing themandrels 88 and the heating mandrels 124 from the diaphragms 4, in use.The inserting rod vacuum system is operable to produce a partial vacuumwithin the internal passage 91 of the diaphragm inserting rods 90 andthe internal passage 89 of the mandrels 88, so as to produce a suctionat a lower end of each mandrel 88 for holding the diaphragms 4 inposition on each mandrel 88, in use.

The applicant envisages that the capsule 12 may be used in particularapplications wherein a capsule is required to hold an additionalsubstance such as, for example, a medicament 130, which is required tobe held apart from the Omega-3 oil 14 contained within the chamber 104.More specifically, the diaphragm 4 of the capsule 12 is filled with themedicament 130 and the capsule 12 is capped, as illustrated in FIG. 3 ofthe drawings, using a conventional capsule capping and filling machinewhich is used to cap known conventional capsule bodies with knownconventional caps 132, so as to form a capsule 134 as shown in FIG. 2 ofthe drawings, each capsule 134 having an additional chamber 136 withinwhich the medicament 130 is contained. Alternatively, the applicantenvisages that in certain circumstances, the capsules 12 and the caps132 will be supplied to a customer of the applicant, thereby permittingthe applicant's customer to fill and cap the capsule 12, with a desiredsubstance contained in the additional chamber 136, using the customersown conventional capsule capping and filling machine.

It will also be appreciated that it is extremely important that theshape and/or dimensions of the open ends 6, 8 of the capsule body 2 andthe diaphragm 4 are maintained when the capsule body 2 and the diaphragm4 are bonded to one another, particularly so as to permit the cap 132 tofit snugly, as shown in FIG. 2 of the drawings. Furthermore, the mannerin which the capsule body 2 and the diaphragm 4 is supported, asdescribed hereinabove, is extremely important to ensure that the shapeand dimensions of the capsule 12 are maintained so as to permit thecapsule 12 to be fed through conventional capsule capping and fillingmachines, which, due to their high speed and precision of operation, canonly process capsules having precise and uniform shapes and dimensions.More specifically, the applicant has found that the supporting of theopen ends 6, 8 of the capsule body 2 and the diaphragm 4, respectively,ensures that the open ends 6, 8 maintain a circular shape when viewed inend view, which is particularly important to ensure a snug fit betweenthe capsule 12 and the cap 132 and to ensure that the shape anddimension of the capsule 12 is maintained, for the reasons set outabove.

The applicant envisages that the digestible capsule 134 is advantageousfor containing two substances, such as, the Omega-3 oil 14 and themedicament 130, which particularly must be held in separate chambersapart from one another. As such, other substances other than the Omega-3oil 14 and the medicament 130 may be held in the chamber 104 and theadditional chamber 136. The applicant furthermore envisages that thecapsule 134 is particularly suitable for holding a wet and a drycomposition, wherein the wet composition is in a liquid state, and, assuch, is required to be held in a hermetic sealed chamber so as toprevent the liquid from leaking out of the hermetically sealed chamber.The applicant envisages that the capsule 134 is furthermore advantageousfor holding two compositions which must be separated from one another soas to prevent degradation and/or reaction and/or contamination of one orboth of the compositions. In particular, the applicant envisages thatthe capsule 134 is advantageous for holding a pharmacologicalcomposition in one of the chambers 104,136 and a natural composition inthe other one of the chambers 104,136.

It will be appreciated that the exact configuration of the apparatus 10used in accordance with the method of the invention, may vary greatlywhilst still incorporating the essential features of the method of theinvention as described hereinabove. Further the apparatus 10 mayimplement a method other than the method in accordance with theinvention and similarly the method in accordance with the invention maybe implemented on an apparatus other than the apparatus 10 describedhereinabove.

The applicant envisages that the capsule body 2, the diaphragm 4 and thecap 132 are formed in accordance with known manufacturing procedures forforming hard gelatine capsules.

The applicant also envisages that the apparatus 10 and the method inaccordance with the invention may be used to manufacture other types ofcapsules other than the digestible capsules 12 and 134 describedhereinabove. More specifically, the applicant envisages that a capsule(not shown) may be produced by the method and/or by the apparatus whichis configured for containing two part compositions which are required tobe separated from one another, such as, for example, highly reactive orexplosive substances, or, alternatively, two part adhesives.

In another embodiment of the invention (not shown), the apparatusincludes a combined diaphragm inserting and capsule bonding assemblywhich replaces the diaphragm inserting assembly 24 and the capsulebonding assembly 28. The combined diaphragm inserting and capsulebonding assembly (not shown) is located with the vacuum chamber 56. Assuch, both the insertion of the diaphragm 4 into the capsule body 2, ashereinabove described, and the bonding of the capsule body 2 and thediaphragm 4 to one another, as hereinabove described, occurs within thecontrolled gaseous environment of the vacuum chamber 56.

The invention claimed is:
 1. A method for manufacturing a capsule forholding a substance to be held in hermetic isolation, comprising:providing a first capsule portion of flexible material for holding thesubstance, the first capsule portion having a closed end, an opposedopen end and a predetermined length defined therebetween; providing asecond capsule portion of flexible material having a closed end, anopposed open end and a predetermined length defined therebetween, whichis shorter than the length of the first capsule portion; at leastpartially filling the first capsule portion with the substance;inserting the closed end of the second capsule portion into the open endof the first capsule portion until the open ends of the first capsuleportion and the second capsule portion are aligned substantially flushwith one another and such that a region of the second capsule portionoverlaps a region of the first capsule portion to close off the open endof the first capsule portion and define a chamber within which thesubstance is held; bonding the substantially flush aligned open ends ofthe first capsule portion and the second capsule portion to one anotherto hermetically seal the chamber after inserting the closed end of thesecond capsule portion into the open end of the first capsule portion;at least partially filling the second capsule portion with an additionalsubstance; and securing a cap to the first capsule portion to define anadditional chamber within which the additional substance is held,wherein the cap is secured to the first capsule portion after bondingthe substantially flush aligned open ends of the first capsule portionand the second capsule portion to one another.
 2. The method as claimedin claim 1, further including supporting the open ends of the firstcapsule portion and the second capsule portion while bonding thesubstantially flush aligned open ends of the first capsule portion andthe second capsule portion to one another.
 3. The method as claimed inclaim 2, further including supporting inner and outer sides of the firstand second capsule portions at an open end region adjacent thesubstantially flush aligned open ends of the first capsule portion andsecond capsule portion.
 4. The method as claimed in claim 1, wherein thesubstantially flush aligned open ends of the first capsule portion andthe second capsule portion are bonded to one another by applying heatand pressure to the open ends of the first and second capsule portionsto fuse the open ends of the capsule portions to one another.
 5. Themethod as claimed in claim 1, further including bonding the overlappingregions of the first capsule portion and the second capsule portion toone another.
 6. The method as claimed in claim 5, wherein theoverlapping regions are bonded to one another by applying heat andpressure to the overlapping regions.
 7. The method as claimed in claim6, further including: providing a gas-tight chamber and providing acontrolled gaseous environment within the gas-tight chamber; locatingthe first and second capsule portions within the gas-tight chamber; andinserting the closed end of the second capsule portion into the open endof the first capsule portion while the first and second capsule portionsare located within the gas-tight chamber.
 8. The method as claimed inclaim 7, further including: providing a non-toxic gas environment withinthe gas-tight chamber; and inserting the closed end of the secondcapsule portion within the first capsule portion while the capsuleportions are located within the non-toxic gas environment.
 9. The methodas claimed in claim 7, wherein a partial vacuum is applied to thegas-tight chamber to reduce gas pressure within the gas-tight chamber toa sub-atmospheric pressure when inserting the closed end of the secondcapsule portion into the open end of the first capsule portion.
 10. Themethod as claimed in claim 1, wherein the first capsule portioncomprises a cylindrical body which defines the open end and the closedend, the closed end being dome-shape.
 11. The method as claimed in claim1, wherein the second capsule portion comprises a cylindrical body whichdefines the open end and the closed end, the closed end beingdome-shape.
 12. The method as claimed in claim 1, wherein the firstcapsule portion and the second capsule portion are both formed ofdigestible material.
 13. The method as claimed in claim 1, wherein thefirst capsule portion, the second capsule portion and the cap are formedof digestible material.
 14. An apparatus for manufacturing a capsule,comprising: a capsule receiver including at least one capsule receivingformation configured to receive therein a first capsule portion offlexible material for holding the substance therein, the first capsuleportion having a closed end, an opposed open end and a predeterminedlength defined therebetween; a capsule filling assembly including one ormore nozzles for dispensing the substance, being operable to at leastpartially fill the first capsule portion which is supported, in use, bythe capsule receiver; a capsule handler including at least one capsulehandling formation configured to handle a second capsule portion offlexible material having a closed end, an opposed open end and apredetermined length defined therebetween, which is shorter than thelength of the first capsule portion, the capsule handler beingdisplaceable between: a first condition wherein the capsule handlingformation is spaced apart from the capsule receiving formation; and asecond condition wherein the capsule handling formation is operable toinsert a closed end of the second capsule portion handled thereby withinthe first capsule portion received by the capsule receiving formationuntil the open ends of the first and second capsule portions are alignedsubstantially flush with one another and such that a region of thesecond capsule portion overlaps a region of the first capsule portionclosing off the open end of the first capsule portion to form anassembled capsule defining a chamber within which the substance is held;and a capsule bonding assembly comprising a bonding head that directlyengages and bonds the substantially flush aligned open ends of the firstcapsule portion and the second capsule portion of each assembled capsuleto one another to hermetically seal the chamber.
 15. The apparatus asclaimed in claim 14, wherein the capsule receiving formation isconfigured for supporting an open end region of the first capsuleportion defined adjacent the open end of the first capsule portion. 16.The apparatus as claimed in claim 14, wherein the capsule handlingformation is configured to be inserted through the open end of thesecond capsule portion for supporting an open end region of the secondcapsule portion defined adjacent the open end of the second capsuleportion.
 17. The apparatus as claimed in claim 14, wherein the bondinghead applies heat and pressure to the first and second capsule portionsof the assembled capsules thereby bonding the first and second capsuleportions to one another.
 18. The apparatus as claimed in claim 17,wherein the bonding head defines an end engaging formation configured toengage directly the substantially flush aligned open ends of the firstand second capsule portions to apply heat and pressure to the open endsthereby bonding the open ends of the first and second capsule portionsto one another.
 19. The apparatus as claimed in claim 18, wherein thebonding head has a second capsule engaging formation configured toengage the inner side of the second capsule portion to apply heat andpressure to the second capsule portion to bond the overlapping regionsof the first and second capsule portions to one another.
 20. Theapparatus as claimed in claim 14, further including a gas-tight chamberwithin which the first and second capsule portions are located wheninserting the second capsule portion into the first capsule portion whenforming an assembled capsule to achieve a controlled gaseous environmentwithin the chamber of the assembled capsule.
 21. The apparatus asclaimed in claim 20, further including a vacuum device which applies apartial vacuum to the gas-tight chamber to reduce gas pressure withinthe gas-tight chamber to a sub-atmospheric pressure.